FDA 510(k) Applications for Medical Device:
Amplifier, Physiological Signal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K051852 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92612 |
| K963669 | ASTRO-MED, INC. |
600 EAST GREENWICH AVE. | WEST WARWICK | RI | 02893 |
| K202174 | Blackrock Microsystems |
630 Komas Drive, Suite 200 | Salt Lake City | UT | 84108 |
| K223676 | BrainMatterZ, LLC |
19830 FM 1093 | Richmond | TX | 77407 |
| K103140 | CAREFUSION 209, INC. |
1850 Deming Way | Middleton | WI | 53562 |
| K203331 | CGX, LLC |
8445 Camino Sante Fe, Suite 104 | San Diego | CA | 92121 |
| K053606 | EB NEURO, S.P.A. |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K121996 | EB NEURO, S.P.A. |
9001 WESLEYAN ROAD | INDIANAPOLIS | IN | 46268 |
| K003154 | EB NEURO, S.P.A. |
7992 CASTLEWAY DR. | INDIANAPOLIS | IN | 46250 |
| K133517 | EB NEURO, S.P.A. |
9001 WESLEYAN RD, STE 200 | INDIANAPOLIS | IN | 46268 |
| K041198 | EB NEURO, S.P.A. |
7992 CASTLEWAY DRIVE | INDIANAPOLIS | IN | 46250 |
| K040113 | EB NEURO, S.P.A. |
7992 CASTLEWAY DR. | INDIANAPOLIS | IN | 46250 |
| K172312 | eemagine Medical Imaging Solutions GmbH |
Gubenerstr. 47, Fabrik D-10243 | Berlin | ||
| K171397 | EMS Handels Gesellschaft m.b.H. |
Jochingergasse 1 | Korneuburg | A-2100 | |
| K123255 | G.TEC MEDICAL ENGINEERING GMBH |
SIERNINGSTRASSE 14 | SCHIEDLBERG | 4521 | |
| K171669 | g.tec medical engineering GmbH |
Sierningstrasse14 | Schiedlberg | 4521 | |
| K060803 | G.TEC MEDICAL ENGINEERING GMBH |
SIERNINGSTRASSE 14 | SCHIEDLBERG | 4521 | |
| K201747 | HippoScreen Neurotech Corp. |
2F., No. 578, Ruiguang Rd., Neihu District | Taipei City | 11492 | |
| K090957 | I2S MICRO IMPLANTABLE SYSTEMS, LLC |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K052060 | INTELLIGENT HEARING SYSTEMS |
7356 S.W. 48 ST. | MIAMI | FL | 33155 |
| K151600 | LIFELINES LTD. |
7 CLARENDON COURT | OVER WALLOP | SO20 8HU | |
| K083322 | NEUROMETRIX, INC. |
62 FOURTH AVE. | WALTHAM | MA | 02451 |
| K092699 | NEUROTRONICS, INC. |
912 NE 2ND ST. | GAINESVILLE | FL | 32601 |
| K220631 | Neurotronics, Inc. |
4500 NW 27th Ave STE C2 | Gainesville | FL | 32606 |
| K972515 | PRO-TECH SERVICES, INC. |
12826 N.W. 178TH ST., SUITE A | WOODINVILLE | WA | 98072 |
| K063599 | TMS INTERNATIONAL BV |
7744 SWAPS TRAIL | EVERGREEN | CO | 80439 |
| K060374 | TMS INTERNATIONAL BV |
7744 SWAPS TRAIL | EVERGREEN | CO | 80439 |
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